DETAILED ACTION
Notice of Pre-AIA or AIA Status
This action is made in response to the amendments/remarks filed on 07/16/2025. This action is made final.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 07/16/2025 has been entered. Claim 1 remains pending in the application. Claims 2-20 have been cancelled.
Information Disclosure Statement
The information disclosure statement filed 01/26/2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. This objection specifically refers to the foreign patent document number EP1704818A.
Drawings
The drawings are objected to because the drawings are unreadable, specifically Fig. 4-8. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is 166 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In Paragraph [0022], “retrieve and real-time data” should read “retrieve real-time data”
In Paragraph [0080], “retrieve and real-time data” should read “retrieve real-time data”
In Paragraph [0083], “They system” should read “The system”
In Paragraph [0088], “The system may at 1014 may” should read “The system at 1014 may”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 discloses “applying an algorithm to the real-time and databases data to generate a quantifiable value of a status of a patient”, but provides no description of the algorithm for generating the quantifiable value claimed. Specifically, the specification merely repeats the functionality found in the claim language, i.e., “an algorithm for the detection of acute use and quantification of withdrawal”. As such, there is no indication in the specification that the inventor had possession of an algorithm used to generate a quantifiable value of a status of a patient, wherein the status relates to at least one of a withdrawal state or a detection of drug usage.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a database of addiction treatment and patient data” in line 3, then further recites “applying an algorithm to the real-time and databases data” in line 5. It is unclear whether there is one database or multiple databases. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the claim is being interpreted as having one database.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: Claim 1 is drawn to a method (i.e., process), which is within the four statutory categories.
Step 2A – Prong One: The claims are analyzed to evaluate whether they recite a judicial exception.
Claim 1 recites:
A method implemented by one or more processors of a device to treat an addiction, the method comprising:
providing a database of addiction treatment and patient data;
providing real-time data, wherein providing the real-time data includes:
generating a plurality of visual representations each corresponding to a plurality of patients, wherein the visual representation is generated based on modelling at least one of: biometric, clinical, locational, and behavioral data;
presenting on a display to a treatment provider a dashboard view comprising an aggregation of the plurality of visual representations, wherein each visual representation visually communicates a patient status to the treatment provider;
enabling the treatment provider to use a GUI to select one of the plurality of visual representations; and
in response to a selection, presenting on a display additional clinical data pertaining to a patient of the plurality of patients that corresponds to the selected one of the plurality of visual representations; and
applying an algorithm to the real-time and databases data to generate a quantifiable value of a status of a patient, wherein the status relates to at least one of a withdrawal state or a detection of drug usage.
These steps amount to a form of managing personal behavior or relationships or interactions between people, and therefore fall within the scope of a method of organizing human activity. Fundamentally, the process is that of a provider receiving information from another person or computer for the patient regarding their addiction treatment. Providing a database of patient data, treatment data, and real time data encompasses a provider interacting with a patient or another individual to obtain the information. A provider can then use the gathered data from the interaction previously described to generate visual representations corresponding to the patients, select the visual representations, present the visual representations, and generate a metric that represents the status of a patient, which encompasses interacting with other individuals. Therefore, this claim recites an abstract idea of managing interactions between people. (Step 2A – Prong 1: Yes).
Step 2A - Prong Two: In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. The additional elements are underlined above in the “Step 2A – Prong One” section.
The additional elements of a processor, a database, an algorithm, presenting on a display, a dashboard view, and a GUI are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. The limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
The limitation “presenting on a display… a dashboard view” is mere data gathering and output recited at a high level of generality, and thus is insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting.
The above claim is therefore directed to an abstract idea without practical application. (Step 2A – Prong 2: NO)
Step 2B: In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is/are sufficient to ensure that the claims amount to significantly more than the judicial exception. This analysis is also termed a search for an "inventive concept." An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
As discussed above in “Step 2A – Prong 2”, the identified additional elements in Independent Claim 1 are equivalent to adding the words “apply it” on a generic computer. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself.
Additional element of “presenting on a display… a dashboard view” was found to be insignificant extra-solution activity in Step 2A, Prong Two, because it was determined to be insignificant limitations as necessary data gathering and outputting. However, a conclusion that an additional element is insignificant extra-solution activity in Step 2A, Prong Two should be re-evaluated in Step 2B. See MPEP 2106.05, subsection I.A. At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well understood, routine, and conventional in the field. See MPEP 2106.05(g).
Generic computer components recited as performing generic computer functions that are well- understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Here, the claim limitations are similar to receiving and sending information over a network (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OJP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); See MPEP 2106.05(d)(II)(i)).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea. Accordingly, Claim 1 is rejected under 35 U.S.C.101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens (US Patent Application Publication 2021/0398648 A1) in view of McNair (US Patent No. 11,069,446 B1), in further view of Rabinowitz et al. (US 2012/0265552) (Hereinafter Rabinowitz).
With respect to Claim 1, Stevens discloses:
A method implemented by one or more processors (Stevens [0151], implemented using a general purpose/specialized digital computer or microprocessor) of a device to treat an addiction (Stevens [0003], describes invention relates to chemical dependency related treatments), the method comprising:
providing a database (Stevens Fig. 2: database of relevant patient data);
providing real time data (Stevens Fig. 2: real-time location, biometric, and physiological data), wherein providing the real time data includes:
applying an algorithm (Stevens [0058]: machine learning module may vet rules by running them against large data-sets) to the real-time and databases data (Stevens Fig. 2) to generate a quantifiable value of a status of a patient (Stevens Fig 4, step 425 tabulate response score), wherein the status relates to at least one of a withdrawal state or a detection of drug usage (Stevens [0058]: Rules are utilized by artificial intelligence module to make decisions regarding a user’s state or probability of a relapse).
However, Stevens does not explicitly disclose the following that is met by McNair:
McNair teaches, a database of addiction treatment and patient data (Col. 9, lines 3-5: a treatment/relapse logging system; McNair Fig. 1, item 160) that includes historical data for patient addiction treatment.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the database of patient data of Stevens to include a database of historical patient addiction treatment data as taught my McNair since the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Stevens already discloses a database comprising of patient data, location data, biometric data, and physiological data, and adding the relevant addiction treatment data as taught by McNair would perform the same function of providing a database of patient data in Stevens, making the results predictable to one of ordinary skill in the art (MPEP 2143).
However, Stevens and McNair do not teach the following limitations that are met by Rabinowitz:
generating a plurality of visual representations each corresponding to a plurality of patients (See Rabinowitz Abstract, [0130], [0137]: Dashboards can include one or more graphs including a representation of a total number of patients and a set of the patients that have a common status relative to a metric), wherein the visual representation is generated based on modelling at least one of: biometric, clinical, locational, and behavioral data (See Rabinowitz Fig. 2, Fig. 9B, [0137], [0160]: Each graph can include a metric indicator and one or more performance indicators indicating the metric and clinical status categories of the data represented by the graph. In one embodiment, the patients are categorized based on blood pressure data on the graph);
presenting on a display to a treatment provider a dashboard view comprising an aggregation of the plurality of visual representations (See Rabinowitz Fig. 1, Fig. 9C, Fig. 10A, [0125], [0144]: The subject technology can include a clinical dashboard for organized display that displays one or more graphs), wherein each visual representation visually communicates a patient status to the treatment provider (See Rabinowitz [0137]: the dashboard can include one or more graphs (for example, bar graph) for monitoring compliance with each of the displayed metrics. Interval markers may be used, for example, to determine or approximate how many patients have met a certain threshold);
enabling the treatment provider to use a GUI to select one of the plurality of visual representations (See Rabinowitz [0132], [0173], [0174]: A user can simply click on a graphic or symbolic representation of the deficiency and the dashboard will bring up the names of the patients, their contact information, and the clinical information that was used to generate the report of a deficiency. A user interface can be configured to make selections on the dashboard.); and
in response to a selection, presenting on a display additional clinical data pertaining to a patient of the plurality of patients that corresponds to the selected one of the plurality of visual representations (See Rabinowitz [0127], [0174]: On receiving a selection at user interface, one or more commands may be generated to retrieve clinical information from database and display the information in an organized manner. Patient-level detail reports can be presented prospectively); and
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combination of Stevens and McNair to include the dashboard view and selection controls as taught by Rabinowitz because analysis and reports regarding groups of patients based on up-to-date, actionable, clinical data can assist health systems and physicians to improve the quality of care for their patients while managing the cost of care. In addition, accurate reports that are actionable in connection with individual patients may increase compliance with the recommended preventive services. Furthermore, providing data regarding specific patients in connection with analysis and reports pertaining to groups of patients can promote action in connection with those patients and provide a powerful tool for improvement (See Rabinowitz par. 5).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly added claim limitations pertaining to generating a plurality of visual representations, a dashboard, using a GUI to make selections, and displaying additional clinical data, have necessitated the new grounds of rejection, and Rabinowitz is now cited to address the newly amended claim limitations.
Applicant has not addressed the objections of the drawings and specification or the rejection of claim 1 under 35 U.S.C. 112 and 35 U.S.C. 101 in the Remarks, filed 07/16/2025, and therefore, the rejections and objections are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Arora (US Patent Application Publication US 2019/0247281 A1) describes a system, method, and apparatus for substance dependence cessation management involving a device, network in communication with the device, and a substance packet dispenser. The system collects user information and used it with an algorithm to define a plan of care for the patient.
Sato et al (US Patent Application Publication 2019/0139146 A1) describes a risk analysis system and method for analyzing risk related to the health of a subject. It utilizes a storage apparatus that stores patient information and an analyzer that analyzes a risk of an event onset.
Williams (US Patent No. 11,388,546 B2) describes a system and method for monitoring and lowering the risk of addiction by using location-based data.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXIS K VAN DUZER whose telephone number is (571)270-5832. The examiner can normally be reached Monday thru Thursday 8-5 CT.
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/A.K.V./ Examiner, Art Unit 4162
/MARC Q JIMENEZ/ Supervisory Patent Examiner, Art Unit 3681